Glenmark Generics receives ANDA approval from the U.S. FDA for Verapamil SR tablets
Release Date: 2009-09-18
September 18, 2009: Glenmark Generics Limited’s (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Verapamil 240mg Extended Release tablets and will immediately commence marketing and distribution in the U.S. market.Verapamil SR tablets are indicated for the management of essential hypertension and are the generic equivalent of Isoptin SR® tablets. The 240 mg strength has more than half the market share of the overall Verapamil SR product line. Total sales for the twelve month period ending June 2009 was USD 65 million, as per IMS Health.
Terrance Coughlin, Chief Executive Officer, Glenmark Generics Limited commented “This approval and launch holds significance for Glenmark Generics as it marks our entry into the extended release segment which is a differentiated and niche segment. This segment has tremendous potential in the US generics market and over the past few years, we have invested resources to build expertise in this specialized area. Besides this approval, we have also filed a number of ANDAs in the Extended Release segment that are pending for approval with the US-FDA”
Today’s approval expands Glenmark’s current portfolio to a total of 49 generic products authorized for distribution in the U.S. market. The Company currently has over 45 ANDA’s filed with the U.S. FDA pending approval. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio
About Glenmark Generics Ltd.
Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader. GGL has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and has over 30 USDMFs approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. [www.glenmark-generics.com]
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. The company is listed on India’s two premier stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5500 people across its global operations over 85 countries. The Company is a leader in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The company has a significant presence in branded generics markets across emerging economies including India.
In December 2008, Glenmark bagged the prestigious SCRIP award for the “Best Pharma Company in the World – SME” and the “Best Company in Emerging Markets” at the SCRIP Awards 2008 in London. For more information on GPL, log on to http://www.glenmarkpharma.com/
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